Clinical Trial: Tenofovir in HIV/HBV Coinfection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection

Brief Summary: The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)

Detailed Summary: A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
Sponsor: Kirby Institute

Current Primary Outcome: To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group

Original Primary Outcome: Same as current

Current Secondary Outcome: -HBV resistance at 48 weeks; -undetectable HBV DNA at weeks 12 & 24; -HBeAg and HBsAg seroconversion at weeks 24 & 48; -ALT chnages and rate of hepatic cytolysis; -HIV-1 RNA supression and CD4/CD8 changes over 48 weeks;

Original Secondary Outcome: To evaluate the emergence of HBV resistance at 48 weeks; To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group; To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks

Information By: Kirby Institute

Dates:
Date Received: September 11, 2005
Date Started: January 2004
Date Completion:
Last Updated: March 30, 2015
Last Verified: March 2015